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Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy

NCT ID: NCT03609892

Last Updated: 2019-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

658 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-08-20

Brief Summary

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This study aims at evaluating efficacy and safety of berberine- amoxicillin containing quadruple therapy(berberine, amoxicillin, esomeprazole and bismuth) versus tetracycline-furazolidone quadruple therapy (tetracycline, furazolidone, esomeprazole and bismuth) in H. pylori rescue therapy. It is hypothesized that berberine-amoxicillin containing quadruple therapy is non-inferior to tetracycline-furazolidone quadruple therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Detailed Description

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Detailed Description:

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 13 and 17.

Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test，rapid urease test or helicobacter pylori stool antigen test。

Conditions

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Gastric Ulcer Chronic Gastritis Gastric Cancer Helicobacter Pylori Infection Gastritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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berberine plus amoxicillin quadruple therapy

Berberine 500mg three time daily for 14days, amoxicillin 1000 mg, esomeprazole 20 mg, and Bismuth 200mg by mouth, twice daily for 14 days.

Group Type EXPERIMENTAL

Berberine

Intervention Type DRUG

Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，esomeprazole 20 mg BID, ,and Bismuth 100 mg 2 capsules BID.

Amoxicillin

Intervention Type DRUG

Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of Amoxicillin 500 mg 2 capsules BID plus berberine 100 mg 3 tablets TID, esomeprazole 20mg 1tablet BID, and bismuth 100 mg 2 capsules BID

Esomeprazole

Intervention Type DRUG

Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of Esomeprazole 20mg 1 tablet BID plus berberine 100 mg 3 tablets TID,amoxicillin 500 mg 2 capsules BID, and bismuth 100 mg 2 capsules BID

Bismuth

Intervention Type DRUG

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of Tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID

tetracycline plus furazolidone quadruple therapy

Tetracycline 500mg three time daily for 14days，furazolidone 100 mg, esomeprazole 20 mg, and Bismuth 200mg by mouth, twice daily for 14 days.

Group Type ACTIVE_COMPARATOR

Tetracycline

Intervention Type DRUG

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of Tetracycline 250mg 2 capsulesTID plus furazolidone 100mg 1 tablets BID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID

Furazolidone

Intervention Type DRUG

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus Tetracycline 250mg 2 capsulesTID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID

Esomeprazole

Intervention Type DRUG

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of esomeprazole 20 mg 1 tablets BID plus Tetracycline 250mg 2 capsules TID, furazolidone 100mg 1 tablets BID， and bismuth 100 mg 2 capsules BID

Bismuth

Intervention Type DRUG

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of bismuth 100 mg 2 capsules BID plus Tetracycline 250mg 2 capsules TID ，furazolidone 100mg 1 tablets BID and esomeprazole 20 mg 1 tablets BID

Interventions

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Berberine

Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，esomeprazole 20 mg BID, ,and Bismuth 100 mg 2 capsules BID.

Intervention Type DRUG

Amoxicillin

Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of Amoxicillin 500 mg 2 capsules BID plus berberine 100 mg 3 tablets TID, esomeprazole 20mg 1tablet BID, and bismuth 100 mg 2 capsules BID

Intervention Type DRUG

Esomeprazole

Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of Esomeprazole 20mg 1 tablet BID plus berberine 100 mg 3 tablets TID,amoxicillin 500 mg 2 capsules BID, and bismuth 100 mg 2 capsules BID

Intervention Type DRUG

Bismuth

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of Tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID

Intervention Type DRUG

Tetracycline

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of Tetracycline 250mg 2 capsulesTID plus furazolidone 100mg 1 tablets BID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID

Intervention Type DRUG

Furazolidone

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus Tetracycline 250mg 2 capsulesTID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID

Intervention Type DRUG

Esomeprazole

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of esomeprazole 20 mg 1 tablets BID plus Tetracycline 250mg 2 capsules TID, furazolidone 100mg 1 tablets BID， and bismuth 100 mg 2 capsules BID

Intervention Type DRUG

Bismuth

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of bismuth 100 mg 2 capsules BID plus Tetracycline 250mg 2 capsules TID ，furazolidone 100mg 1 tablets BID and esomeprazole 20 mg 1 tablets BID

Intervention Type DRUG

Other Intervention Names

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Amoxy Nexium Nexium

Eligibility Criteria

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Inclusion Criteria

1. Patients who had failed H.pylori eradication therapies before.
2. Age between 18\~70, both gender.
3. Patients who had failed H.pylori eradication therapies during last 2 years and stop the eradication therapies for at least 2 months.
4. Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

Exclusion Criteria

1. Patients are excluded if they have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori.
2. Contraindications to study drugs.
3. Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
4. Constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening).
5. Pregnant or lactating women.
6. Underwent upper gastrointestinal Surgery.
7. Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
8. Evidence of bleeding or iron efficiency anemia.
9. A history of malignancy.
10. Drug or alcohol abuse history in the past 1 year.
11. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
12. Enrolled in other clinical trials in the past 3 months.
13. Patients who has psychological problem or poor compliance.
14. Refuse to sign informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role lead

Responsible Party

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Yongquan Shi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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Zhang J, Han C, Lu WQ, Wang N, Wu SR, Wang YX, Ma JP, Wang JH, Hao C, Yuan DH, Liu N, Shi YQ. A randomized, multicenter and noninferiority study of amoxicillin plus berberine vs tetracycline plus furazolidone in quadruple therapy for Helicobacter pylori rescue treatment. J Dig Dis. 2020 May;21(5):256-263. doi: 10.1111/1751-2980.12870. Epub 2020 Jun 9.

Reference Type DERIVED
PMID: 32348007 (View on PubMed)

Other Identifiers

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KY20182043-1

Identifier Type: -

Identifier Source: org_study_id